Message from the CPME President:

Dear colleagues and friends,

T he CPME Board and General Assembly met on 23 May in Reyk-javik, Iceland. The event marked a new cycle of elections and I am proud and honoured of the outcome: we elected the new

Executive Committee for the mandate 2016-2018, including the President-Elect, Dr Jacques de Haller (Switzerland) as a representative of European doctors from 29 National Medical Associations. I will not dwell on the full details of results as you will find further details on page 2. I would simply congratulate the President elect, the four Vice-Presidents, the Treasurer and the new members of the CPME Board. Furthermore, I am equally delighted to welcome new members to the CPME, namely the Croatian Medical Association as full member and also EMSA (the European Medical Students Association) as our associated organisation with whom we co-operate most closely for many years. It is important that European doctors stand together and help to shape the fu-ture of Europe. It is about Europe that I want to say a few words. My message to you, EU institution representatives, Comissioners, MEPs is a simple one: think forward but do not exclude the core of professional representation where it is most wanted. The fast pace of big reforms, the restructuring of governance at EU level should not be fragmented into hundreds of calls for expression of interest. CPME wants to continue the stable cooperation. The new proposals for restructuring the EU Health Policy Forum, the Pa-tient Safety and Quality of Care Expert Group, the eHealth Joint Action should neither affect this cooperation, nor burden communication. Since 1959 we are contributing to public health, workforce and prevention poli-cies, we owe it to patients, we owe it to the profession to represent them well and adequately, so it is our sincere hope to see this through and make our voice heard in the future and thus contribute to a healthy Europe. Yours sincerely, Dr Katrin Fjeldsted CPME President

CPME Newsletter Special edition I S S U E

M a y 2 0 1 5

16

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This issue CPME Executive Committee & Board 2016-2018 - outcome of elections P. 2 - 3 Biographic note: Dr Jacques de Haller CPME President-Elect P. 4 Newly adopted policies, 23 May - Reykjavik (Iceland) P. 4 Croatian Medical Chamber full member-ship to CPME P. 4 EMSA becomes Associated Organisation in CPME P. 4 Interview: MEP Glenis Willmott (S&D, UK) P. 5 CPME discussed TTIP—What way for-ward for healthcare? P. 6 Health databases & biobanks—ethical considerations P. 6 One Health’ - European doctors re-affirm commitment to cooperation with Europe-an veterinarians P. 7 Expiration dates of pharmaceuticals—a CPME position paper P. 8 What of Complementary & Alternative Treatments? ‘P. 8 Discussion group on health with Dr MEPs P. 9 EU Institutional news, CPME news P. 10

on page 5 INTERVIEW — mep glenis Willmott (S&D, UK): medical devices and ttip.

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France 1st Vice‐President

The Netherlands 2nd Vice‐President

Hungary 3rd Vice‐President

Belgium 4th Vice‐President

Prof. Dr Frank‐Ulrich MONTGOMERY

Germany Treasurer

Dr Patrick ROMESTAING Dr Rutger van der GAAG

Dr Istvan ÉGER Dr Bernard MAILLET

Dr Jacques de HALLER

Switzerland CPME President‐Elect

2016‐2018

CPME executive committee

2016-2018

Dear colleagues,

T he CPME Board and General Assembly met in Reykjavik (Iceland) on 23 May

2015. A decisive element of legitimate and democratic professional associations

is the holding of elections. Our General Assembly elected the CPME Board,

President, four Vice-Presidents and a Treasurer. The term of office starts on 1 January

2016 for a period of three years until 31 December 2018.

Congratulations to the winning candidates!

Sincerely yours,

RA Birgit Beger

CPME Secretary General

Dr Patrick ROMESTAING Dr Rutger van der GAAG

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CPME Board

2016-2018

Austria

Dr Reiner BRETTENTHALER

Ireland

Dr Neil BRENNAN

Belgium

Dr Bernard MAILLET

Latvia

Dr Gunta ANCĀNE

Bulgaria

Dr Yuliya BYANKOVA

Lithuania

Dr Daiva BROGIENĖ

Croatia

Dr Hrvoje ŠOBAT

Luxembourg

Dr Claude SCHUMMER

Cyprus

Dr Marios KARAISKAKIS

Malta

Dr Martin BALZAN

The Czech Republic

Dr Milan KUBEK

The Netherlands

Prof. Dr Rutger Jan van der GAAG

Denmark

Dr Andreas RUDKJØBING

Norway

Dr Hege GJESSING

Estonia

Dr Indrek ORO

Poland

Dr Konstanty RADZIWIŁŁ

Finland

Dr Heikki PÄLVE

Romania

Dr Mircea CINTEZĂ

France

Dr Patrick ROMESTAING

Slovakia

Dr Ludmila LYSINOVA

Germany

Prof. Dr Frank Ulrich MONTGOMERY

Slovenia

Dr Andrej MOŽINA

Greece

Dr Anastasios VASIADIS

Sweden

Dr Karin BÅTELSON

Hungary

Dr István ÉGER

Switzerland

Dr Jacques DE HALLER

Iceland

Dr Katrín FJELDSTED

The United Kingdom

Dr Terry JOHN

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Issue 16: May 2015

Dr Jacques de Haller is the CPME President-elect with a term beginning 1st Janu-

ary 2016 until 31 December 2018. Dr Jacques de Haller was born in 1952; he

graduated from Geneva University Faculty of Medicine in 1978 and specialised in

Family Medicine (1983). He worked as a GP in Geneva for 21 years (1983-2004).

He became President of the Swiss Association of General Practitioners for 4 years,

in 2000. In 2004, he was elected President of the Swiss National Medical Associa-

tion, until December 2012.

During his 8-year mandate, he developed the association – representing 97% of

the Swiss doctors into becoming one of the major political lobbies in Switzerland.

Correct tariffication, limitation of administrative burden on physicians, hurdle free

access for all patients to the needed medical care, and the preservation of a pa-

tient-doctor relationship, the core of medicine in his view, free of state or insurance

interventions, were the main accents of his national presidency. He was elected

Vice-President of CPME in June 2012 and his activities in CPME include the areas

of self-care, mental health, occupational health, physicians’ health.

Dr Jacques de HALLER

Switzerland CPME President‐Elect

Biographic note

CPME Spring meetings: policy outcomes On 23 May 2015, the CPME Board adopted the following health pol-icy statements: CPME position paper on rules regarding expiration dates of pharmaceu-

ticals (CPME 2014/074 Final).

CPME Position paper on Complementary and Alternative Treat-

ments (CPME 2013/130 FINAL).

CPME response to the WMA public consultation on the WMA Declara-

tion on ethical considerations regarding health databases and biobanks

(CPME 2015/039 Final).

The European Medical

Students’ Association

(EMSA) was also ac-

claimed as the newest

CPME Associated Or-

ganisation.

The same day, the CPME General Assembly voted unanimously in favour of full membership of the Cro-atian Medical Chamber to CPME.

Pascal Nohl-Deryk, EMSA Policy-Making Officer Athanasios Vaiopulos, EMSA Permanent Officer to CPME

Dr Hrvoje ŠOBAT

Croatian Medical Chamber, CPME Board

member‐Elect

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IntERVIEW—mep glenis Willmott (s&d, uk):

~THE WAY FORWARD ON MEDICAL DEVICES AND TTIP ~

On the draft proposal for a regulation on medi-

cal devices – what are the main expectations

as Rapporteur and in the coming trialogue ne-

gotiations?

This is a huge, very technical piece of legislation,

which covers a number of controversial issues, so

we know that finding a compromise between the

European Parliament’s position and the position of

28 different Member States isn’t going to be easy.

My priority will be to find a sensible agreement –

we need legislation that works and, most im-

portantly, we need legislation that ensures the

highest standards of patient safety.

A wide range of implementing and delegated acts are foreseen in the draft proposal for a regulation on

medical devices. If the regulation is adopted in this format, do you have any worries concerning the trans-

parency behind the follow-up on implementing and delegated acts?

Implementing and delegated acts are used to allow the Commission to determine certain technical details of legis-

lation, which politicians simply don’t have the necessary expertise to decide. Of course, we will have to be careful

to ensure that this isn’t used as a way for the Commission to make decisions that should be made at a political lev-

el and MEPs must play a key role in scrutinising any proposals to make sure they remain in the spirit of what was

intended by the legislators.

What are the main benefits of the future regulation for European patients and doctors as main users of

medical devices?

Our priority for this regulation has to be patient safety. Patients must be able to have confidence that devices be-

ing used on them, or implanted in them, have been properly scrutinised before being placed on the market, and

that a rigorous system of post-market surveillance is in place to identify any unforeseen problems. We also want to

make sure patients are given full information about devices implanted in them and that they can be easily traced

through a Unique Device Identification (UDI) system. Clearly, patient safety is also the primary concern of medical

practitioners, so it's equally important to have a system that they can be confident in, too. If we can build a more

transparent system, doctors should be able to access more information about devices, allowing them to make in-

formed decisions about which devices to use.

How would you see the TTIP negotiations impacting on medical devices in the European Union? Is there a

possibility to foresee an alignment of standards? What would be the benefits or pitfalls on medical devic-

es as a result of TTIP?

It's very difficult to say at this stage, as TTIP is still under negotiation and we won't know for a while what the final

agreement will look like. However, Labour MEPs have been clear that TTIP shouldn't lead to a lowering of regula-

tory standards in the EU. The idea of establishing a transatlantic traceability system is certainly interesting in terms

of making it easier for patients and doctors to get information on devices, but we would have to look very carefully

at any proposals.

Interview carried out by:

Anamaria Corca

Issue 16: May 2015

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CPME discusses TTIP – what way forward for

healthcare?

I n a discussion of the CPME Board on 23 May

2015, CPME assessed the status quo of the

Transatlantic Trade and Investment Partnership

(TTIP) Agreement’s approach on healthcare. Since

the adoption of the CPME policy on the Transatlantic

Trade and Investment Partnership Agreement (TTIP)

in November 2014, the European Commission has

made efforts to provide information and clarifications

as to the agreement’s scope and impact. Statements

have indicated that TTIP will not prevent Member

States from organising public services including

health as they wish; also the regulatory competence

to legislate to protect public interest objectives is not

to be restricted. At the same time, the strong public

opposition to the proposals for an investor-to-state dispute settlement (ISDS) mechanism as voiced by the

public consultation has prompted the Commission to review it approach in this area. The CPME Board

agreed on follow-up action to call on Member States to effectively safeguard their healthcare systems. The

chair of the CPME WG on TTIP, Dr Heikki Pälve, summarised that “Doctors do acknowledge the potential

economic benefits this agreement can deliver, however it is important that there are no unintentional effects

on healthcare. CPME will therefore continue to highlight the need for a special approach for this sector.”

For further information, please contact:

Sarada Das

O n 9 April, the World Medical Association (WMA) opened a public consultation on a draft declaration

on ethical considerations regarding health databases and biobanks. The WMA draft declaration

aims to clarify certain ethical aspects of the use of health data and material contained in large scale

repositories. In particular, a governance structure is proposed for the use of data and material through a

broad consent scheme. This new approach responds to the ever growing need to make the best use of infor-

mation contained in repositories and to guarantee at the same time that individuals’ rights are protected.

It is expected that the Declaration, when adopted, will become an important ethical guidance document for a

constantly evolving research environment. In a letter to the WMA, CPME expressed its support for this initia-

tive.

Please see here the CPME response to the consultation: CPME 2015/039.

Additional information about the draft declaration and the open public consultation is available on the WMA

website.

For further information, please contact:

Constance Colin.

HEALTH DATABASES & BIOBANKS: Ethical considerations

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F ollowing the successful cooperation established by a Memorandum of Understanding on action

against antimicrobial resistance signed in 2013, the CPME Board, at its meeting in Reykjavík on

23 May 2015, adopted the Memorandum of Understanding between the Federation of Veterinari-

ans of Europe (FVE) and CPME on the concept of ‘One Health’. The memorandum reaffirms the coopera-

tion on antimicrobial resistance and envisages collaboration on a broader set of topics including profes-

sional issues and the negotiations towards a Transatlantic Trade and Investment Partnership (TTIP)

Agreement. “A strengthened exchange between the animal and human health sectors will improve poli-

cies’ effectiveness and impact,” FVE President Dr Christophe Buhot explained, “by collaborating as pro-

fessional organisations we look forward to promoting the ‘One Health’ approach for a healthier Europe.”

CPME President Dr Katrín Fjeldsted also welcomed the consolidated basis for cooperation highlighting

that “veterinarians and doctors can now jointly highlight the importance and benefit of tackling issues from

a ‘One Health’ perspective. Joining forces strengthens professionals’ voice to strive for better healthcare.”

One recent example of cooperation is CPME’s participation in a panel debate at the FVE conference

‘Natural disasters and One Health: Are we prepared?’ which took place in Brussels on 17 April 2015. The

conference conclusions highlight that preparedness planning and disaster management must adopt a

‘One Health’ approach to ensure the effective protection of people and animals.

For further information, please contact: Sarada Das

‘One Health’ - European doctors re-affirm

commitment to cooperation with European

veterinarians

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O n 23 May 2015, the CPME Board adopted the CPME position paper on rules regarding expiration

dates of pharmaceuticals. Every year a large amount of pharmaceuticals is destroyed while most of

them may still be usable. Since a big proportion of pharmaceuticals has a high potency long after the

expiration date, if they are stored and handled the right way, one might assume that pharmaceuticals are de-

stroyed despite the high quality of the products. The waste of these pharmaceuticals has both an environ-

mental and economic impact.

The CPME position paper underlines the need for a reflection at EU level on this issue and calls upon the

European Commission to consider the possibility of extending expiration dates for pharmaceuticals and thus

revise the applicable rules.

The CPME position paper is available here : CPME 2014/074.

For further information, please contact: Constance Colin

A recently published CPME position paper on complementary and alternative treatments informs the

public, EU institutions and physicians of several guiding principles on this topic:

Misleading advertising and the right to information

EU and national legislators within their respective competence should ensure that the trust of patients and

citizens is not abused by permitting misleading information concerning efficacy of conventional medical treat-

ment or of complementary or alternative treatments.

The public should be informed that traditional, alternative and complementary practices are not a specialty

within medicine and therefore forms of certified training within these areas does not constitute specialist

training.

Delay in diagnosis and associated risks

Patients may be led into choosing to use traditional, complementary and alternative practices instead of medi-

cal treatment, resulting in a possible delay of proper scientific medical diagnosis and allowing their condition

to worsen and in some cases leading to early death.

Vulnerable groups

Physicians should be aware that some groups of patients, such as patients with cancer, psychiatric conditions

or severe chronic illnesses and children are particularly vulnerable to risks associated with alternative practic-

es. Where such situations occur, doctors should discuss it with their patients when using CAM treatments

along with their existing medical treatment.

The CPME position paper on Complementary and Alternative Treatments is available here: CPME 2013/130.

For further information, please contact:

Anamaria Corca.

Expiration dates of pharmaceuticals: A CPME Position paper

WHAT OF COMPLEMENTARY & Alternative Treatments?

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E

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T he Standing Committee of European Doctors

(CPME) together with MEP Dr Elena Gentile

(S&D, IT) organised in February 2015 an infor-

mal discussion group on health for Members of the

European Parliament (MEPs) who are medical doc-

tors. The second roundtable event will take place on

the 3rd of June 2015, at 18h00, Room A1E-1 at the

European Parliament. The primary goal of the dis-

cussion group, which aims to develop its activities

throughout the 5 year legislative period, is to defend and guarantee the right to health for a more healthy

society, by sharing knowledge and expertise between Doctor MEPs and CPME.

The second roundtable will focus on relevant topics that the European Parliament has to address on a daily

basis, such as Alcohol, Alzheimer, Transatlantic Trade and Investment Partnership (TTIP), Ethical and

transparent physicians-industry relationships and Standardisation.

For further information, please contact:

Miriam D’Ambrosio

Discussion group on health with Doctor MEPs

Joint conference of the European Medical

Organisations on continuous professional

development

Following the successful collaboration around the conference ‘CPD – Improving healthcare’ in 2006, the Euro-

pean Medical Organisations (EMOs) are planning to hold a joint event in Luxembourg on 18 December 2015.

Issue 16: May 2015

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CPME NEWS

On 22-23 April 2015, CPME Vice President, Dr Milan Kubek, CPME Vice President, Dr István Éger, CPME Vice President, Dr Jacques de Haller and CPME Secretary General, RA Birgit Beger attended the European Forum of Medical Organisations and the World Health Organisation, in Tbilisi, Georgia.

On 7 May 2015, CPME President, Dr Katrín Fjeldsted, CPME Secretary General, RA Birgit Beger and Communi-cation and Project Officer, Miriam D’Ambrosio met with Dr Roberta Chersevani (President of the Italian Medical Federation, FNOMCeO), in Rome, Italy.

On 8 - 9 May 2015, CPME President, Dr Katrín Fjeldsted attended the General Assemblies of AEMH - European Association of Senior Hospital Physicians, FEMS – European Federation of Salaried Doctors and EJD – European Junior Doctors, in Vienna, Austria.

On 10 May 2015, CPME President, Dr Katrín Fjeldsted and CPME Secretary General, RA Birgit Beger attended the European Medical Organisations’ Presidents’ Meeting, in Vienna, Austria.

On 11-13 May 2015, CPME Immediate Past President, Dr Konstanty Radziwill and EU Policy Advisor, Constance Colin attended the eHealth week in Riga, Latvia. The theme of this year’s event was mHealth. During the week the mHealth Green Paper Stakeholders’ Meeting was held and its aim was to discuss future policy actions on mHealth with stakeholders. These discussions were based on the results of the public consultation on the Green Paper on mHealth.

.

CPME Meetings 2015-2016 SAVE THE DATES!

Brussels 30-31 October 2015

Athens 13-14 May 2016

Brussels 25-26 November 2016

EU Institutional News

18-19 June Brussels, Belgium. The meeting of the Council configuration on Employment, Social Poli-cy, Health and Consumer Affairs (EPSCO) will discuss health relevant topics such as medi-cal devices.

8 June Brussels, Belgium. The meeting of the Patient Safety and Quality of Care WG at EU level will include representatives of EU MS, health professional representative organisations, patients and other relevant stakeholders. Further information, please see here.

3 June Brussels, Belgium. Conference on 'Innovative Financing Opportunities for Active & Healthy Ageing' This conference organised by DG Santé focuses on the issue of how to strengthen the public and private financial instruments and how to empower synergies related to active and healthy ageing.

01 June Brussels, Belgium. Conference "Endocrine disruptors: criteria for identification and related impacts". The aim of the conference is to inform Member States, Members of the European Parliament (MEPs), third countries representatives and stakeholders about the on-going impact assessment on criteria to identify endocrine disruptors and to provide a platform for further exchanges of views. For more information about the event, click here.

26 - 29 May The Hague, the Netherlands. Meeting of the Joint ECDC/WHO Surveillance Network for Tu-berculosis and Wolfheze Workshops. This workshop brings together experts from countries belonging to the WHO European Region and EU/EEA countries to discuss the common goal of eliminating TB in Europe. More info available here.

CPME Mission Statement

The Standing Committee of European Doctors (CPME) represents national medical asso-ciations across Europe. We are committed to contributing the medical profession’s point of view to EU and European policy-making through pro-active cooperation on a wide range of health and healthcare related issues.

We believe the best possible quality of health and access to healthcare should be a reality for everyone. To achieve this, CPME promotes the highest level of medical training and practice, the safe mobility of physicians and patients, lawful and supportive working conditions for physicians and the provision of evidence-based, ethical and equitable healthcare services. We offer support to those working towards these objectives whenev-er needed.

We see the patient-doctor relationship as fundamental in achieving these objectives and are committed to ensuring its trust and confidentiality are protected while the relation-ship evolves with healthcare systems. Patient safety and quality of care are central to our policies.

We strongly advocate a ‘health in all policies’ approach to encourage cross-sectoral awareness for and action on the determinants of health, to prevent disease and promote good health across society. CPME’s policies are shaped through the expertise provided by our membership of nation-al medical associations, representing physicians across all medical specialties all over Europe and creating a dialogue between the national and European dimensions of health and healthcare.

Editorial Board

Birgit Beger CPME Secretary General

Sarada Das

Senior EU Policy Advisor

Constance Colin EU Policy Advisor

Essi Saarto

CPME EU Policy Intern

Athanasios Vaiopoulos CPME Intern - EMSA Permanent Officer to CPME

Editors

Anamaria Corca EU Policy Advisor

Miriam D’Ambrosio

Communication & Project Officer